510(k) K973916

NP MEDICAL CAPLESS LUER ACTIVATED VALVE by Np Medical, Inc. — Product Code FPA

K973916 is an FDA 510(k) premarket notification submitted by Np Medical, Inc. for the device "NP MEDICAL CAPLESS LUER ACTIVATED VALVE". The FDA issued a decision of Substantially Equivalent on March 9, 1998. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Np Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1998
Date Received
October 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type